近日elliptical,FDA官网发布了关于阿斯利康召回替卡格雷elliptical,该公司将替卡格雷与其生产elliptical的另外一个产品雷西纳得混淆,装在同一个瓶子里并已放行销售。
有关该报道elliptical的原文摘译如下:
AstraZeneca today announced that the Company is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of BRILINTA® (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of BRILINTA 90mg also contained another medicine called ZURAMPIC® (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.
阿斯利康今天宣布该公司正式通知医生和消费者,他们正主动召回一批专业(医生)样品瓶,包含8片BRILINTA®(替卡格雷)90mg/片。该主动召回附带一个报告:8片/瓶的BRILINTA(替卡格雷)90mg/片里面还装有另外一个药品ZURAMPIC®雷西纳得200mg/片。
Unintentional dosing with ZURAMPIC has the potential to lead to adverse renal effects including acute renal failure which is more common when ZURAMPIC is given alone as it should be used in combination with a xanthine oxidase inhibitor.
服用ZURAMPIC有潜在的导致肾功能不良,包括急性肾功能衰竭,这在单独服用ZURAMPIC时比其与黄嘌呤氧化酶抑制剂组合使用时更加明显。
Missed doses of BRILINTA increases the risk of heart attack and stroke. People who are treated with a stent and miss doses of BRILINTA have a higher risk of getting a blood clot in the stent, having a heart attack, or death.
而BRILINTA给药不足将增加心肌梗死和中风的危险。使用血管内支架治疗的人群在BRILINTA给药不足的情况下,有更高的风险导致血管支架血栓、心肌梗死,甚至死亡。
BRILINTA 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with 90 above a T on one side of the pill. ZURAMPIC tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side of the pill.
BRILINTA®(替卡格雷)90mg/片是圆形、两面凸起、黄色、薄膜包衣片,一面印有“90”和“T”字样。ZURAMPIC®雷西纳得200mg/片是蓝色椭圆型的,一面印有“LES200”字样。
BRILINTA®(替卡格雷)
ZURAMPIC®(雷西纳得)
来源:GMP办公室